Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients

This study has been completed.
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01146743
First received: June 9, 2010
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

The investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.


Condition Intervention
Cholecystitis
Procedure: EUS-guided gallbladder drainage
Procedure: percutaneous transhepatic gallbladder drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Clinical response rate [ Time Frame: Within 72 hours from procedure ] [ Designated as safety issue: Yes ]
    Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.


Secondary Outcome Measures:
  • Complication rate [ Time Frame: Complications during the procedure or within 1 weeks ] [ Designated as safety issue: Yes ]
    Complication was defined as any procedure-related complications during the procedure or within 1 week, including bile leakage, pneumoperitoneum, bleeding, and etc.

  • Conversion rate [ Time Frame: During laparoscopic cholectstectomy ] [ Designated as safety issue: Yes ]
    Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy.


Enrollment: 59
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EUS-guided
EUS-guided gallbladder drainage in acute cholecystitis with high risk patients
Procedure: EUS-guided gallbladder drainage
EUS-guided gallbladder drainage was performed with a linear-array echoendoscope. The initial puncture was performed at the antrum of the stomach or bulb of the duodenum and was chosen to access the gallbladder body or neck and avoid visible vessels. After removal of the needle, a 6F or 7F bougie were inserted and then removed to dilate the tract. Afterward, nasobiliary drainage tube or stent was placed.
Other Name: EUS-guided transmural drainage
Active Comparator: percutaneous transhepatic
percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients
Procedure: percutaneous transhepatic gallbladder drainage
Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
Other Name: percutaneous cholecystostomy

Detailed Description:

The primary outcome is to compare clinical resolution rate of EUS-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage in acute cholecystitis patients with high risk.

The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)

Exclusion Criteria:

  • Age below 18 years
  • Pregnancy
  • When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure.
  • Unstable or unwilling to comply with follow-up
  • When a perforated viscus is known or suspected
  • Simultaneously participating in another investigational drug or device study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01146743

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Director: SangSoo Lee, M.D. Asan Medical Center
  More Information

Publications:
Responsible Party: SangSooLee/professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01146743     History of Changes
Other Study ID Numbers: EUS_GB1
Study First Received: June 9, 2010
Last Updated: March 16, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
EUS-guided transmural cholecystostomy

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 01, 2014